Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies

NCT00470743 | Withdrawn Phase 4

• 1 other identifier: SQPDA02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born under 29 weeks gestation

Conditions

Ductus Arteriosus, Patent; Very Low Birth Weight Infants

Keywords

Ibuprofen; Indomethacin; Infant, very low birth weight; Prematurity; Ductus Arteriosus, patent

Outcome Measures

Primary Outcomes (1)

• Incidence of oliguria and gastric bleeding

  within one week of treatment

Secondary Outcomes (13)

• PDA closure rates after medical treatment at time of discharge from hospital

  after 1 to 2 courses of treatment

• Need for repeat of the second course of medication

  48 hrs after 3rd dose of treatment

• Need for surgical closure

  after 1 to 2 courses of treatment

• In-hospital mortality

  while in-hospital

• Creatinine >140umol/L within one week after the 1st dose of treatment

  one week after 1st dose of treatment

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Compare ibuprofen

Drug: Ibuprofen

Normal saline

PLACEBO COMPARATOR

Compared against ibuprofen -- placebo

Drug: Indomethacin

Interventions

Ibuprofen DRUG

Ibuprofen

Indomethacin DRUG

Normal saline

Eligibility Criteria

• Age: Up to 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \<29 weeks gestation with a PDA diameter of \>= 1.5 mm on 2Dechocardiogram
• Parental written informed consent - Parent agrees to the subject's participation in the study as indicated by parent's signature on the consent form
• Parent is willing to comply with procedures/treatment and is able to keep to scheduled study assessments

You may not qualify if:

• Major congenital malformations in the opinion of the investigator
• Necrotising enterocolitis
• Gastrointestinal Perforation
• Systemic illness other than PDA, not fit for the trial in the opinion of the investigator
• The parent is in the opinion of the investigator, mentally or legally incapacitated
• The parent is unwilling/unable to comply to study procedures

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• National University Hospital, Singapore: collaborator
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

KK Women's and Children's Hospital / National University Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Interventions

Ibuprofen; Indomethacin

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Quek Bin Huey, MMed MRCP

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 8, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 2, 2015

Record last verified: 2009-06

Locations

SG (1)